US Food and Drug Administration revised EUA for sotrovimab due to Omicron BA.2 subvariant
On Mar. 25, 2022, GlaxoSmithKline and Vir Biotechnology announced that the US Food and Drug Administration had amended the Emergency Use Authorization (EUA) Fact Sheet for sotrovimab, an investigational monoclonal antibody.
The FDA had determined that, based on the totality of available evidence, including new live virus data generated by Vir, it is unlikely that the sotrovimab 500 mg dose will be effective against the Omicron BA.2 variant. GSK and Vir were preparing a package of data in support of a higher dose of sotrovimab for the Omicron BA.2 subvariant and shared these data with regulatory and health authorities around the world for discussion.
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Source: Vir Biotechnology
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